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U.S. Department of Health and Human Services

Class 2 Device Recall Think Surgical Cutter

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  Class 2 Device Recall Think Surgical Cutter see related information
Date Initiated by Firm March 30, 2018
Create Date August 06, 2018
Recall Status1 Terminated 3 on January 24, 2020
Recall Number Z-2605-2018
Recall Event ID 80091
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428

The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
Code Information Lot Numbers 9158, 9519, 9209, 9230, 9269, 9288, 9834, 9869, 10201, 100496, 1626303, 9287, 9563, 9642, 9855, 9890, 10313
Recalling Firm/
Manufacturer		 Think Surgical, Inc.
47201 Lakeview Blvd
Fremont CA 94538-6530
For Additional Information Contact
510-249-2300
Manufacturer Reason
for Recall		 There is a potential for the cutter head to detach from the cutter shaft.
FDA Determined
Cause 2		 Process control
Action The firm, Think Surgical Inc., sent an "Urgent Medical Device Recall" notices dated 3/30/2018 to customers on 3/30/18. The notices instructed customers to perform the following actions: Examine your inventory, locate any unused devices noted above and quarantine them immediately. If you have received any accessory kits from THINK surgical Incorporated with the noted cutter part numbers included, do not use any affected product and return any unused product to the company. THINK Surgical Incorporated has provided you with a Returned Material Authorization Form (RMA), a FedEx Envelope and return FedEx AirBill to retun any unused devices. Your account will receive a credit and replacement units will be sent. Fill out the accompanying Acknowledgement Form. Email the completed Acknowledgement Form to Ms. Meliha Mulalic at mmulalic@thinksurgical.com. Contact THINK Surgical Incorporated QA/RA Group at 510-249-2337, attention Ms. Meliha Mulalic, should you have any questions. Urgent Medical Device Recall Information: Lot Number Correction letters dated 4/4/18 were distributed as well. The letters corrected an error in the initial notification letter which alerted customers to a typographical error in which lot 9159 should read 9519.
Quantity in Commerce 951
Distribution The devices were distributed to the following US states: NJ, NY, OH, and TX. The devices were also distributed to Korea.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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